Sunday, 19 April 2015

ClinicSpeak: generic glatiramer acetate and more pharma shenanigans

How loyal will MSers be to Copaxone, the brand? #ClinicSpeak #MSBlog #MSResearch

"This is probably old news for you, but the FDA licensed a generic version of glatiramer acetate last week. The excerpts from the press article below cover the most important issues."

"It is interesting to note that because of an ongoing patent dispute the actual launch of the generic version of GA will be delayed. Momenta and Sandoz, who will co-market the generic GA, have been in numerous court battles with Teva who make Copaxone. Momenta and Sandoz are trying to invalidate a patent held by Teva which expires in September 2015. If Momenta and Sandoz launch the generic GA before September, they risk a court decision that would force them to remove the drug from the market and a counter-claim from TEVA for loss of revenue due to the illegal competition. In the meantime, my US colleagues are telling me that Teva are frantically trying to switch all US MSers on Copaxone from their original 20-mg daily formulation to the new 40-mg three times a week formulation. The latter formulation has patent protection until 2028. It is clear that TEVA want to retain as many of MSers on their product as possible to maintain their revenue stream."

"The same issues are likely to arise in Europe. It is interesting that with biologicals the issues are different. Even if biologics come off patent it is very costly and difficult to get a biosimilar licensed. This is why the majority of top earning drugs are now biologicals and why Pharma now favours biologics over small molecules. The latter are easy to copy. Any guesses how much generic GA will cost compared to Copaxone? When small molecules come of patent the price of generics are typically 90% cheaper within 2 years. With biosimilars the drop is only about 30%. GA is not really a small molecule, or a biologic, but I guess due to the manufacturing issues it will probably behave in a similar way to and hence I predict the generic version will probably be about 30% cheaper. Let's wait and see. I sincerely hope this is not the case in the developing world where MSers are in desperate need for cheap and effective DMTs."

"Another issue is brand loyalty. On my recent trip to India I was horrified that Indian Neurologists favoured Rituxan (rituximab) over the Indian biosimilar Reditux, which cost a third of the price of the innovator product. They simply felt the innovator compound was superior despite data showing similar levels of peripheral B cell depletion. When I told my wife this story she said why was I surprised, I should never underestimate the power of the brand. Generic GA will be a test of how powerful Copaxone is as a brand. I would be interested to hear from any MSers out there who are on GA how they would feel being switched from Copaxone, a brand they know and trust, to cheaper generic version?"

.... Federal regulators ...... approved the first generic MS therapy, a development that could drop the price of the drug for consumers and boost the business of Momenta Pharmaceuticals Inc., which produced the injectable treatment.....

...... The generic version of the MS drug Copaxone will be sold under the brand name Glatopa by the Sandoz division of Switzerland’s Novartis AG, which signed an agreement with Cambridge-based Momenta to market the generic.....

..... Glatopa was approved as a “substitutable generic" for patients taking Copaxone, an injectable sold by Israel's Teva Pharmaceutical Industries Ltd. for MS, a degenerative disease of the central nervous system. “Given its complexity, we reviewed additional information to make sure the generic product is as safe and effective as the brand-name product,” said Janet Woodcock, director of the Food and Drug Administration’s drug evaluation unit......

..... Sandoz and Momenta have not disclosed when they will launch Glatopa commercially in the United States or how it will be priced in relation to Copaxone, which competes with such MS drugs as Avonex from Biogen Inc. of Cambridge and Rebif from EMD Serono Inc. of Rockland.....

..... The list price for a year’s worth of Copaxone, which is injected daily, is more than $60,000 per patient. Insurers cover the bulk of the cost for most patients.......

...... “We won’t discuss our pricing strategies publicly ahead of launch but our general goal, as always, would be to offer patients and payers a real alternative to the originator,” said Julie Masow, a spokeswoman for Novartis.....

..... A long-running patent dispute pitting Teva against Sandoz and Momenta is working its way through the federal courts, but it’s not clear if that will delay the launch....

> They simply felt the innovator compound was superior despite data showing similar levels of peripheral B cell depletion.We got many domestic (ronbetal, infibeta) and iranian (cinnovex) interferon formulations.Almost everyone with whom I talked on this, both patients and neuros, agree on that domestic biosimilars < iranian biosimilar < original formulations. The adhesion is poorer, side effects are less tolerable, patients do worse.All of them claimed to be as effective as originals as demonstrated in clinical trials, of course.All this could be biased, of course. But do the geography of those trials play a role? It is much easier to see the efficacy of the rituximab similars to deplete cells... And this is not the case with generic small molecules, but for biologicals used in chronic diseases like MS... i believe there is a question who and where do the trials.

These posters say that based on expression profiling of T cells copaxone and generic copaxone are essentially the same...so one can be reasonably confident that based on efficacy they are probably the same.. i.e, low efficacy.

I think this will be a fascinating natural experiment ... but it's going to tell us more about the US health PAYMENT system than anything particular to MS or Copaxone. Specialty drugs - and the pricing / coverage / cost-sharing thereof - are nearing a flash point right now, with the hepatitis C drugs as the spark, and the collection of MS drugs as fuel for the fire once it starts.

So long as we're in the existing payment scheme (and humor me and consider our hodge-podge as a single scheme), then my guess is that a 30% price drop will not be enough to significantly change much of anything. That will only happen if insurance companies place the generic GA as the ONLY MS drug in a lower tier than other DMTs. If they go the route of making generic GA the preferred formulation but placing it in the same tier as a preferred interferon (branded) and dimethyl fumerate (branded), then I'm guessing that a non-trivial number of Copaxone (40) users would opt to change drugs rather than stick to GA with daily dosing.

Existing insurance schemes (tiered formularies and extreme cost sharing) leave DMTs out of reach for some and I don't see how the generic GA is going to change that unless we also see significant changes to insurance schemes. A 30% price drop still leaves it at ~$10,000 for a 3 month supply. Anyone with an insurance scheme based on percentage cost-share is just as SOL ... that 30% price drop doesn't make it accessible to anyone for whom it isn't already accessible.

I'm a little concerned. I was eager to take 40mg GA--who wouldn't be? But after about a week, I had a mild reaction (itchy, redness, and a few hives). It didn't make sense to me, but my neuro put me back on 20mg, and I've been fine ever since. I get allergic to weird things lately--terrible reactions to gadolinium, too. So the prospect of changing any drugs worries me. My guess is that my insurer (I'm in the US) will require me to take the generic.

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